Method of assembly of catheter package

ABSTRACT

A soft and pliable latex rubber catheter for body orifice use is assembled with a relatively rigid tube sheath by inserting the tip end of the catheter shaft into one end of the tube sheath, and applying a suction to the other end of the tube sheath to effect longitudinal movement of the catheter shaft into the tube, while leaving one end of the catheter free and extending from the open one end of the tube sheath. The assembled tube and catheter are then overpackaged by inserting such into a flexible dual sheet having a pocket therein with an open mouth, and thereupon heat sealing the open mouth closed. Prior to overpackaging the free end of the tube sheath may be heat sealed closed to prevent prelubrication bleeding or staining of the overpackage, particularly when packaging catheters with prelubricated shafts.

United States Patent 11 1 Patton METHOD OF ASSEMBLY OF CATHETER PACKAGE[75] Inventor: William L. Patton, North Canton,

[63] Continuation of Ser. No. 349,788, April 10, 1973, abandoned, whichis a continuation of Ser. No. 150,067, June 4, 1971, abandoned,

52 us. Cl 53/21; 53/37 51 int. c1. B65B 5/04; B65B 7/14; B6513 1/16 [58]Field of Search 53/21,22, 24, 37, 35,

53/39; 128/349 R; 206/336, 337, 338, 438, 206/439, 440, 441, 63.2 R,63.2 A

[56] References Cited UNITED STATES PATENTS 3,169,308 2/1965 Goran, Jr.53/35 X 3,169,527 2/1965 Sheridan 206/632 R X 3,279,595 10/1966 Blanford.t 206/632 R 3,338,019 8/1967 Trewella et al. 206/632 R X 3,366,2261/1968 Baklor 206/632 R X /4/ VACUUM SOURCE [4 1 May 20, 1975 PrimaryExaminer-Travis S. McGehee Assistant ExaminerHorace M. Culver Attorney,Agent, or Firm-Reginald F. Pippin, Jr.

[57] ABSTRACT A soft and pliable latex rubber catheter for body orificeuse is assembled with a relatively rigid tube sheath by inserting thetip end of the catheter shaft into one end of the tube sheath, andapplying a suction to the other end of the tube sheath to effectlongitudinal movement of the catheter shaft into the tube, while leavingone end of the catheter free and extending from the open one end of thetube sheath. The assembled tube and catheter are then overpackaged byinserting such into a flexible dual sheet having a pocket therein withan open mouth, and thereupon heat sealing the open mouth closed. Priorto overpackaging the free end of the tube sheath may be heat sealedclosed to prevent prelubrication bleeding or staining of theoverpackage, particularly when packaging catheters with prelubricatedshafts.

8 Claims, 4 Drawing Figures METHOD OF ASSEMBLY OF CATHETER PACKAGE Thisis a continuation, of application Ser. No. 349,788 filed Apr. 10, 1973,which in turn is a continuation of Ser. No. 150,067 originally filedJune 4, 1971, now abandoned.

This invention relates to a method of assembly of catheter packagingarrangements.

It is conventional practice to package urethral and other similarcatheters of the type utilized for fluid input into and/or exit frombody orifices, in suitable point-of-use containers to aid in preventingcontamination of the catheters prior to use. Various containerarrangements have been used, and it has been found desirable in oneunique container arrangement to package the catheter with its long andhighly flexible shaft in a tube sheath, with the tube sheath andcatheter then being overpackaged in an external container. It is afeature of the present invention to provide a satisfactory method ofassembly of such a catheter package arrangement.

Still other objects, features and attendant advantages of the inventionwill become apparent from a reading of the following detaileddescription of a preferred mode of practice of the invention, taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a schematic representation of apparatus for, and steps carriedout in, the assembly of a catheter and tube sheath according to theinvention.

FIG. 2 is a schematic representation illustrating the assembly of thecatheter and tube sheath with an overpackage container.

FIG. 3 is a schematic representation illustrating the final sealing ofthe total package arrangement.

FIG. 4 is a schematic representation illustrating the heat seal closingof the tube sheath after assembly with a catheter as in FIG. 1.

Referring now in detail to the figures in the drawing, according to theinvention and as illustrated in FIG. 1, a catheter 11 is assembled witha tube sheath 2], through the medium of a vacuum source 41 and vacuumconnector 31. It is desirable to insert the shaft 13 of the catheter 11into the longitudinal bore of sheath 21, and due to the very flexibleand pliable nature of the catheter shaft 13, such being conventionallyformed of soft cured latex rubber, the insertion of the shaft 13 intothe tube sheath 21 may pose practical difficulties when such isattempted to be done by pushing the shaft into and along the entirelength of the bore of tube sheath 21. Such insertion, of course, can infact be accomplished manually by small incremental movements through thegrasping of the shaft 13 closely adjacent the open input end of the tubesheath bore and successively regrasping and pushing the shaft inincremental steps into the tube in this manner. However, this is arelatively slow and time-consuming operation, and is particularly moredifficult when the catheter shaft outer diameter closely approximatesthe internal diameter of the tube sheath.

According to the present invention, the tip end 13a of the cathetershaft 13 is manually or otherwise engaged at or inserted a shortdistance, as indicated in broken lines at 13a, into one end of the tubesheath bore 21, and the bore of tube sheath is suitably connected at itsopposite end to a vacuum source 41, as by insertion of the tube sheathopposite end 23 into a fun nel connector 31 which is connected asthrough a fluid conduit 51 to a vacuum source 41. The application of thesuction provided by the vacuum source 41 will effeet a net pulling forceon the catheter shaft 13 to effect a sliding movement of the cathetershaft through the bore of tube sheath 21 until such further movement isblocked by the contact of the branch arm 17 or other enlargement ofconventional construction on the catheter 11. By providing a tube sheath21 of suitable length, as compared to the length of the shaft 13 of thecatheter 11, it will be appreciated that the final position of the tipend 13 of the catheter shaft 13, as indicated in broken lines at 13a,may be desirably disposed within and spaced from the open end 23 of thetube sheath 21.

After vacuum assembly of the catheter 11 with the tube sheath 21 asillustrated in FIG. 1, the assembled catheter 11 and tube sheath 21 areinserted into an overpackage generally indicated at 61 as shown in FIG.2. This may be readily accomplished by pre-forming the overpackage 61from two sheets of flexible material, one of which 63 may be gaspermeable and breathable paper and the other a transparent cover sheetof thermoplastic material 65. The overpackage 61 may be suitablypre-formed in this general configuration by peripheral bonding of thetwo sheets, as by heat sealing and as indicated generally at spacedmultiple heat seal lines 67, to form a pocket 61a which is open at oneend. The package may likewise desirably have at its opposite end anunbonded end flap zone 63a, 65a, so as to enable the two sheets 63 and65 to be readily and easily peeled apart by the operator or an assistantat the time of desired catheter use.

As illustrated in FIG. 2, the catheter and tube sheath assembly, 11, 21is inserted through the open end of the pocket 61a, to a longitudinalposition as generally indicated in broken lines in FIG. 2, andsubsequently the overpackage 61 is sealed as by passing the open endbetween suitable pressure rollers, one or both of which may be heated toeffect a secure multiple-line seal across the previously open throat ofthe pocket 61a, as generally indicated at 69 in FIG. 3. The finalpackage arrangement 11, 21, 61 may be subjected to suitablesterilization, as by vacuum and gas sterilization (e.g. with ethyleneoxide), and if desired sterilization steps may also be effected prior toor after any of the preceding steps as described above.

In some instances, and particularly where the catheter shaft isprelubricated, the packaging method may be modified to effect atransverse heat seal 23a across the end 23 of the tube sheath 21, afterthe step of FIG. 1 and before the step of FIG. 2, as by heated jawclamps 41 as shown in FIG. 4, or by rollers or other suitable sealingmeans as desired.

While the invention has been described with respect to a single mode ofpractice thereof, it will be apparent that various modifications andimprovements may be made without departing from the scope and spirit ofthe invention. For instance, the invention may be applied to variousforms of catheters, other than the catheter construction as illustrated,which is a conventional Foley catheter with fluid drainage and ballooninflation arms, and a single drainage eye in the insertion shaft. Inaddition, while the preferred mode of practice envisions the use of afunnel connector 31 for connection of the vacuum source to the tubesheath, one may also utilize a male coupling, although such poses moredifficulty in suitable mating with the relatively small opening in thetube sheath end. Further, the overpackage may be of other constructionthan the layered sandwich construction illustrated, while stillemploying the novel method aspect of FIG. 1. In addition, the finalsealing of the overpackage may be effected by other means than theheated rollers 71, 73, as by utilizing opposing jaw clamps, one or moreof which may be heated to effect a suitable seal of the thermoplastic 65with the paper base sheet 63. Accordingly, it is to be understood thatthe invention is not to be limited by the illustrative mode of practice,but only by the scope of the appended claims.

I claim: 1. The method of packaging a flexible catheter with a tubesheath therefor which is relatively rigid as compared to such catheter,said catheter having an insertion shaft with an insertion tip end andtwo divergent fluid passage arms as an integral part thereof anddisposed adjacent one end of said insertion shaft, comprisinserting saidshaft into said tube sheath by inserting said insertion tip end of saidcatheter into one end of a bore of said tube sheath, which bore is of asize to freely accommodate sliding movement therethrough of saidcatheter shaft, but insufficient at one end thereof to accommodate andpermit passage therethrough of said two divergent fluid passage arms,effecting a suction on the opposite open end of said tube sheath bore,while said tip end is in said one end of said tube sheath bore to drawthe shaft of said catheter into said tube sheath bore, and blockingcontinued suction-induced movement of said shaft into said tube sheathbore through engagement of the divergent zone formed by said twodivergent fluid passage arms with said one end of said tube sheath,thereby leaving said two divergent fluid passage arms extending beyondthe open said one end of said tube sheath, and thereupon removing saidsuction from said tube sheath.

2. The method according to claim 1,

and thereupon closing said opposite end of said tube sheath.

3. The method according to claim 2,

said closing of said tube sheath opposite end being effected by heatsealing said opposite end of said tube sheath through combined heat andpressure exerted across said opposite end.

4. The method according to claim 3,

and inserting the assembled said catheter and tube sheath into an openended pocket of a pre-formed pouch overpackage,

and sealing said open-ended pocket.

5. The method according to claim 4,

said overpackage having at least one wall formed of gas permeablematerial,

and gas sterilizing the final assembled and sealed package of catheter,tube sheath and overpackage.

6. The method according to claim 2,

and prelubricating the insertion shaft of said catheter prior toassembly with said tube sheath.

7. The method according to claim 6,

and inserting the assembled said catheter and tube sheath into an openended pocket of a pre-fornied pouch overpackage,

and sealing said open-ended pocket,

said overpackage having at least one wall formed of gas permeablematerial,

and gas sterilizing the final assembled and sealed package of catheter,tube sheath and overpackage.

8. The method according to claim 1,

and inserting the assembled said catheter and tube sheath into an openended pocket of a pre-formed pouch overpackage,

and sealing said open-ended pocket,

said overpackage having at least one wall formed of gas permeablematerial,

and gas sterilizing the final assembled and sealed package of catheter,tube sheath and overpackage.

1. The method of packaging a flexible catheter with a tube sheaththerefor which is relatively rigid as compared to such catheter, saidcatheter having an insertion shaft with an insertion tip end and twodivergent fluid passage arms as an integral part thereof and disposedadjacent one end of said insertion shaft, comprising inserting saidshaft into said tube sheath by inserting said insertion tip end of saidcatheter into one end of a bore of said tube sheath, which bore is of asize to freely accommodate sliding movement therethrough of saidcatheter shaft, but insufficient at one end thereof to accommodate andpermit passage therethrough of said two divergent fluid passage arms,effecting a suction on the opposite open end of said tube sheath bore,while said tip end is in said one end of said tube sheath bore to drawthe shaft of said catheter into said tube sheath bore, and blockingcontinued suction-induced movement of said shaft into said tube sheathbore through engagement of the divergent zone formed by said twodivergent fluid passage arms with said one end of said tube sheath,thereby leaving said two divergent fluid passage arms extending beyondthe open said one end of said tube sheath, and thereupon removing saidsuction from said tube sheath.
 2. The method according to claim 1, andthereupon closing said opposite end of said tube sheath.
 3. The methodaccording to claim 2, said closing of said tube sheath opposite endbeing effected by heat sealing said opposite end of said tube sheaththrough combined heat and pressure exerted across said opposite end. 4.The method according to claim 3, and inserting the assembled saidcatheter and tube sheath into an open ended pocket of a pre-formed pouchoverpackage, and sealing said open-ended pocket.
 5. The method accordingto claim 4, said overpackage having at least one wall formed of gaspermeable material, and gas sterilizing the final assembled and sealedpackage of catheter, tube sheath and overpackage.
 6. The methodaccording to claim 2, and prelubricating the insertion shaft of saidcatheter prior to assembly with said tube sheath.
 7. The methodaccording to claim 6, and inserting the assembled said catheter and tubesheath into an open ended pocket of a pre-formed pouch overpackage, andsealing said open-ended pocket, said overpackage having at least onewall formed of gas permeable material, and gas sterilizing the finalassembled and sealed package of catheter, tube sheath and overpackage.8. The method according to claim 1, and inserting the assembled saidcatheter and tube sheath into an opeN ended pocket of a pre-formed pouchoverpackage, and sealing said open-ended pocket, said overpackage havingat least one wall formed of gas permeable material, and gas sterilizingthe final assembled and sealed package of catheter, tube sheath andoverpackage.